BS EN ISO 10993-16:2017 | 31 Mar 2020 | BSI Knowledge
Standard
BS EN ISO 10993-16:2017
Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
Current, Under Review
•
Published:
1 Scope
This document provides principles on designing and performing toxicokinetic studies
relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological
evaluation of medical devices.
Product Details
Descriptors
Decomposition reactions
Leaching
Toxicity
Toxicology
Metabolism
Absorption
Design
Biological analysis and testing
Medical equipment
Degradation
ICS Codes
11.100.20 Biological evaluation of medical devices